Cmc Regulatory Affairs Associate Director
hace 3 meses
**Location: Barcelona, Spain (we requiere 3 days working from the office and 2 days working from home**
Our **Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs** function delivers expert CMC regulatory input for projects spanning across the product lifecycle and leads the regulatory strategy for the development, manufacturing and testing of all our medicines. With our expertise we interpret, anticipate and craft global Health Authority expectations to build CMC and Device Regulatory Strategies.
We are seeking a **CMC Regulatory Affairs Associate Director** to add to our dynamic team in our Barcelona, Spain hub. This role will support the biologics technical area, encompassing both traditional and novel molecules.
As a **CMC Regulatory Affairs Associate Director** you will:
- Use your regulatory experience to devise creative strategies to support a range of new biological entities and novel products, from development to post approval lifecycle management.
- Provide strategic, tactical and operational expertise and direction to AstraZeneca project teams, based on understanding of global CMC regulations.
- Have a high level of interactive social skills and cultural sensitivity which you will use to advise CMC teams on how to achieve successful regulatory outcomes.
- Lead project driven regulatory interactions with health authorities, e.g. FDA, EMA, for CMC scientific advice.
- Lead and/or deliver CMC Regulatory components of business process improvement projects.
- Share your knowledge actively within CMC RA and the wider business, participate in the coaching and mentoring of colleagues and keep up to date with emerging global regulatory requirements.
- You may also be asked to support due diligence reviews.
**Minimum Qualifications**:
- Bachelor’s degree in a science or technical field such as pharmacy, biology, chemistry, or biological science
- Breadth of knowledge of manufacturing, project, technical and regulatory project management
- Strong understanding of regulatory affairs globally, particularly with respect to the CMC field
- Regulatory Affairs CMC experience with submissions for biologics drug substances and products.
**Desired Qualifications**:
- Advanced degree in a science or technical field such as pharmacy, biology, chemistry, or biological science
- Regulatory Affairs CMC experience with submissions for antibody drug conjugates, radioconjugates or bispecifics
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